SEZ SAFETY SYRINGE

K031163 · Sez Corporation · MEG · Jul 8, 2003 · General Hospital

Device Facts

• Record ID: K031163
• Device Name: SEZ SAFETY SYRINGE
• Applicant: Sez Corporation
• Product Code: MEG · General Hospital
• Decision Date: Jul 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries.

Device Story

SEZ Safety Syringe is a piston-style hypodermic syringe for intramuscular and subcutaneous medication delivery. Device consists of calibrated hollow barrel, movable plunger, and needle assembly. Operation mirrors conventional syringes for aspiration and injection. Post-injection safety mechanism involves a turn-pull-push sequence: rotating plunger knob clockwise disassembles needle hub from barrel; pulling plunger backward retracts needle into barrel; pushing plunger forward tilts and crumbles needle within barrel to prevent reuse and needlestick injury. Used by clinicians in healthcare settings. Device ensures safe containment of contaminated needle and fluid for disposal in sharps containers.

Clinical Evidence

Clinical investigation performed in conformity with Annex X of MDD93/42/EEC and FDA guidance for sharps injury prevention features. Study compared SEZ Safety Syringe to the predicate device. Results demonstrated the device is clinically acceptable for its intended use.

Technological Characteristics

Materials: polypropylene (homo type) barrel, thermoplastic rubber gasket, nitrile rubber o-ring. Sterilization: ethylene oxide gas (SAL 10^-6). Design: piston syringe with integrated needle destruction mechanism. Conforms to ISO 7886-1:1993(E) for barrel markings and ISO 10993-1 for biocompatibility.

Indications for Use

Indicated for intramuscular and subcutaneous injection of medication to patients requiring hypodermic delivery; aids in prevention of needlestick injuries.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• EXEL Secure Touch Safety Syringe (K011754)

Submission Summary (Full Text)

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K031163

EXHIBIT 2 SEZ Corporation

#401, Simon Bldg. 943-15. Daechi-dong, Gangnam-Gu, Seoul, Korea Tel: [phone] Fax: [phone] May 19, 2003 Contact: G.S. Pok, Managing Director 510(k) Summary of Safety and Effectiveness

- 1. Identification of the Device: Proprietary-Trade Name: SEZ Safety Syringe Classification Name: Piston Syringe Common/Usual Name: Safety Syringe
- 2. Equivalent legally marketed device: EXEL Secure Touch Safety Syringe, K011754
- 3. Indications for Use (intended use) . This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries.
- 4. Description of the Device: SEZ Safety Syringe consists of 1) a calibrated hollow barrel which contains medication and, after use, confines 2) the needle, 3) a movable plunger which aspirates medication and, after injection, retracts the needle into the barrel, At the distal end of the barrel, there is a female connector(nozzle) for fitting 3) a male connector(hub) to which the needle is firmly attached by bonding material. The needle is securely protected by 5) a cap before use. For sealing purpose, 6) an o-ring, between barrel and hub, and a gasket, between barrel and plunger, are used. The function of the device is to deliver medication and, after injection, to destroy the needle in the barrel to prevent needlestick injury and possible reuse. The injection process is practically the same as that of the conventional, non-safety, syringes, that is, to aspirate medication from a vial and to deliver it to a patient. The disposal process is turnpull-push operation, each step of which is clearly and unmistakably defined. By turning the knob of the plunger half round clockwise, hub is disassembled from the barrel. Then plunger is pulled backward until it stops, which retracts hub and needle into the barrel. Needle is tilted to one-side pushed by the rod at plunger head. Finally, the plunger is pushed forward to crumble the needle in the barrel. Needle and contaminated fluid are contained in the barrel safely and used syringe can be discarded in the sharps container..

JUL 0 8 2003

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| Device name | Predicate syringe<br>EXEL Secure Touch Safety Syringe (K011754) | SEZ safety syringe |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Intended Use | This device is a safety hypodermic syringe<br>for injection of medication to patients.<br>This device aids in prevention of needlestick<br>injuries. | Identical |
| Principle of operation | Activation of safety feature consists of<br>two steps:<br>1) Disassemble needle assembly<br>from the barrel by turning<br>the plunger. | Identical |
| | 2) Retract needle into barrel and<br>confine it in the barrel by<br>pulling the plunger backward.<br>To guarantee confinement of<br>needle, break the plunger<br>before disposal. | Identical,<br>except that needle<br>confinement is<br>guaranteed by pushing<br>the plunger forward<br>before disposal. |
| Volume (ml/cc) | 3 and 5 combined | 3 |
| Nozzle type | Male conical lock fitting with<br>rotatable internally threaded<br>collar | Female conical lock<br>fitting with rotatable<br>internally threaded<br>neck |
| Barrel marking | - Scale : conforms to<br>ISO 7886-1:1993(E) | Identical |
| Reuse | Non-reusable | Identical |
| Biocompatibility | Conforms to ISO 10993-1 | Identical |
| Materials | 1) Plastic parts : polypropylene (homo type)<br>2) Gasket : thermoplastic rubber<br>3) O-ring : nitrile rubber<br>4) Packing film : Medipeel film<br>5) Packing paper : Ethypel paper | Identical<br>Identical<br>Identical<br>Identical<br>Identical |
| Sterility | Sterilized by ethylene oxide gas<br>$SAL=10^{-6}$ | Identical |

- 5. Safety and Effectiveness, comparison to predicate device:
Conclusion: In all material respects, the SEZ Safety Syringed is substantially 6. equivalent to the predicate device. The conclusion is based on biocompatibility testing, clinical testing, compliance with voluntary standards, and comparison to the predicate device. A clinical investigation was performed in conformity with the requirements specified in Annex X of MDD93/42/EEC, and test for the comparison between SEZ Safety Syringe and the legally marketed predicate device was performed in accordance with "Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA". The results of the investigation showed that the SEZ Safety Syringe is clinically acceptable.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles three human profiles facing right, stacked on top of each other, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 0 8 2003

Mr. Daniel Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield. Illinois 60015

Re: K031163

Trade/Device Name: SEZ Safety Intramuscular/Subcutaneous Syringes Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: April 2, 2003 Received: April 15, 2003

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Kamm

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan B. Anno

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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j) Indications for Use 火03 11163 510(k) Number_

Device Name: SEZ Safety Syringe

This device is a safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over the Counter Use__________________________________________________________________________________________________________________________________________________________ OR Prescription Use __ X (Per 21 CFR 801.109)

Patturn Cuccerite

(Division Sign-C Division of Anesthesiology, General Hospital tion Control, Dent

510(k) Number: K031163

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